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Details for Patent: 8,889,186

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Patent 8,889,186 protects ENVARSUS XR and is included in one NDA.

This patent has twenty-seven patent family members in fifteen countries.

Summary for Patent: 8,889,186

Title:Modified release compositions comprising tacrolimus
Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s): Holm; Per (Vanlose, DK), Norling; Tomas (Lyngby, DK)
Assignee: Veloxis Pharmaceuticals A/S (Horsholm, DE)
Application Number:14/079,466
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form; Formulation;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 1st percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Veloxis Pharms Inc
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL206406-001Jul 10, 2015RXNo8,889,186► subscribe PROPHYLAXIS OF ORGAN REJECTION
Veloxis Pharms Inc
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL206406-002Jul 10, 2015RXNo8,889,186► subscribe PROPHYLAXIS OF ORGAN REJECTION
Veloxis Pharms Inc
ENVARSUS XR
tacrolimus
TABLET, EXTENDED RELEASE;ORAL206406-003Jul 10, 2015RXYes8,889,186► subscribe PROPHYLAXIS OF ORGAN REJECTION
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Non-Orange Book Patents for Patent: 8,889,186

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,486,993Solid dispersions comprising tacrolimus► subscribe
7,994,214Solid dispersions comprising tacrolimus► subscribe
8,889,185Modified release compositions comprising tacrolimus► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 8,889,186

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada2537044► subscribe
China1859909► subscribe
China1859910► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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